- Question
- Is reduced-dose apixaban as effective as, and safer than, full-dose apixaban for extended anticoagulation of cancer-associated venous thromboembolism?
- Design
- Randomized, double-blind, phase 3 noninferiority trial with blinded central outcome adjudication; 1766 patients randomized 1:1 and treated for 12 months (median treatment duration 11.8 months).
- Population
- Patients with active cancer and proximal deep-vein thrombosis or pulmonary embolism who had completed at least 6 months of anticoagulant therapy; randomization occurred at a median of 8.0 months after the index event.
- Intervention
- Reduced-dose apixaban 2.5 mg twice daily for 12 months (866 patients).
- Control
- Full-dose apixaban 5.0 mg twice daily for 12 months (900 patients).
- Primary outcome
- Centrally adjudicated fatal or nonfatal recurrent venous thromboembolism, assessed with a noninferiority margin of 2.00 for the upper boundary of the 95% CI of the subhazard ratio.
- Results
- Recurrent venous thromboembolism occurred in 18 patients (cumulative incidence 2.1%) with reduced dose and 24 (2.8%) with full dose (adjusted subhazard ratio 0.76; 95% CI 0.41 to 1.41; P = 0.001 for noninferiority). Clinically relevant bleeding occurred in 12.1% vs 15.6% (adjusted subhazard ratio 0.75; 95% CI 0.58 to 0.97).
- Safety
- Clinically relevant bleeding was less frequent with the reduced dose (12.1% vs 15.6%). Mortality was 17.7% with reduced dose and 19.6% with full dose (adjusted hazard ratio 0.96; 95% CI 0.86 to 1.06).
- Conclusion
- In patients with active cancer, reduced-dose apixaban was noninferior to full-dose apixaban for preventing recurrent venous thromboembolism during extended anticoagulation, with less clinically relevant bleeding.
- Why it matters
- It provides evidence to consider a reduced apixaban dose when extending anticoagulation in patients with cancer-associated venous thromboembolism, aiming to keep protection against recurrence while lowering bleeding risk.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026